#533 - How They Lie, Part 6: The True Story of Alar, Part 4, 12-Feb-1997

In late February, 1989, Natural Resources Defense Council (NRDC), a
mainstream environmental organization, published a lengthy report on
pesticides endangering children's health.[1] The CBS TV news show, "60
Minutes," publicized NRDC's findings February 26, 1989. Most of the "60
Minutes" show was spent describing the government's pesticide-
regulation process, which was incapable of keeping industrial
carcinogens (cancer-causing chemicals) out of the nation's food supply.
However, the opening images of "60 Minutes" highlighted an apple
overlaid by a skull and crossbones while a voice described the threat
from Alar, and that is what stuck in peoples' minds. To this day, most
people think the "60 Minutes" show was all about Alar on apples. In
reality, the show was about government failure to protect the food
supply from cancer-causing industrial chemicals --a problem that still
has not been resolved.

Back in 1989, Alar offered an excellent example of failed regulation.
By 1989, high doses of Alar (or its contaminant and breakdown
byproduct, UDMH) had been shown to cause cancer in male and female
mice, male and female hamsters, and male rats. The International Agency
for Research on Cancer had labeled UDMH a "possible" carcinogen in
humans and the U.S. government's National Toxicology Program had
labeled UDMH a "probable" human carcinogen, as had the Carcinogen
Assessment Group within U.S. Environmental Protection Agency [EPA].
(See REHW #530, #531, #532.) The acting chief of the EPA, John A.
Moore, had said on February 1, 1989, "There is an inescapable and
direct correlation between exposure to UDMH and the development of
life-threatening tumors in mice."[2] Yet Alar/UDMH was still legal for
apples.

Government officials did not miss the point of the "60 Minutes"
program, and they moved quickly to defend their record. On March 16,
1989, Frank E. Young, chief of the Food and Drug Administration (FDA),
issued a press release[3] which offered a joint statement by FDA, EPA
and USDA [U.S. Department of Agriculture], reassuring the public that
apples were safe. The press release made several key points:

2. FDA monitors apples and often finds no Alar, or amounts of Alar that
are less than the allowable limit.

3. Only 5% of the U.S. apple crop was treated with Alar in 1988.

In sum, the government's assurances boiled down to this: yes, Alar/UDMH
causes cancer in animals but Alar isn't used on most apples, so apples
and apple products are safe.

As it turned out, this attempt to reassure the public backfired. In
May, 1989, CONSUMER REPORTS (CR) magazine published an independent
analysis of Alar on apples purchased in the New York area and reported
finding Alar residues on 55% of them.[4] Edward Groth of Consumers
Union subsequently revealed that FDA itself has found Alar on 38% of
the apples it had tested in 1988.[5] Furthermore, CR revealed that the
FDA was using antiquated and insensitive laboratory techniques which
could not measure Alar below 500 parts per billion (ppb). As CONSUMER
REPORTS said, "Looking for daminozide [Alar] in apple juice with PAM II
[the test method used by FDA] is like trying to catch speeders with a
radar gun that doesn't work for speeds under 100 mph." [FDA
subsequently adopted the more sensitive test method recommended by
CONSUMER REPORTS.] After CR reported its independent Alar measurements,
several state governments and news organizations conducted surveys of
their own and reported finding Alar on 22% to 79% of red apples all
across the country.[6] On average, it appears, about half of all red
apples for sale in 1989 had been sprayed with Alar, not 5%. It was
clear that FDA, EPA and USDA were badly misinformed or were lying.

The apple industry, too, began distributing false information about
Alar. The industry paid more than a million dollars to Hill & Knowlton,
a large PR firm, to design and run ads saying that you would have to
eat a box-car-load of apples each day to be harmed by Alar.

The rationale behind such an argument is that laboratory animals were
exposed to high doses of Alar and UDMH, to see if high doses would
produce cancers. For humans to be exposed to equivalent high doses,
they would have to eat a box-car-load of apples each day. However, this
is a dishonest representation of the science involved.

Just because high doses cause cancer in animals, it does not mean that
ONLY high doses cause cancer in animals. Among public health
authorities in the U.S., the assumption is that cancer-causing
chemicals follow a linear dose-response curve: if 10 milligrams of a
substance causes 4 cancers in 10,000 people, then 5 milligrams will
cause two cancers in 10,000 people and 2.5 milligrams will cause one
cancer in 10,000 people. However, it is also true that 2.5 milligrams
will also cause 2 cancers in 20,000 people and 4 cancers in 40,000
people. Under this linear dose-response assumption, exposing a large
population (such as half of all the people who eat red apples) to a
carcinogen like Alar/UDMH will cause cancer in some of them, even
though none of them received a high dose.

High doses are used in animals studies because only 20 to 200 animals
are used in any experiment. This is so because it is expensive to
maintain large populations of animals under experimental conditions. If
a certain dose of a cancer-causing chemical were sufficient to cause
cancer in one out of every 10,000 animals, testing that same dose on
200 animals would not reveal any effect. (A chemical that caused cancer
in one among every 10,000 exposed people would create a real public
health calamity; if all 250 million Americans were exposed to such a
chemical, it would cause 25,000 cancers. This would be a public health
disaster by anyone's reckoning.) Therefore, to try to detect
carcinogens that might affect only one in 10,000, or one in 100,000
animals (or people), yet not test more than about 200 animals (for cost
reasons), high doses must be used to see if any effect can be observed.
This approach may not satisfy everyone, but no one has yet suggested a
better alternative.

Therefore, there are good reasons for testing high doses on animals,
and there is no good reason for saying that people have to be exposed
to the same high doses for them to be endangered. The argument, "You
would have to eat a box-card-load of apples every day to be endangered
by Alar" is specious, false, not valid, untrue.

John Rice of the International Apple Institute admitted in a public
forum in June, 1989, that the "boxcar" ads were a dishonest
representation of the science of Alar and cancer, but he justified the
dishonesty by saying that the "60 Minutes" use of an apple with a skull
and crossbones was dishonest, too.[7] (The "boxcar" argument was first
used by Uniroyal, the manufacturer of Alar, in 1985 and it was as
dishonest then as it was in 1989.[8])

Another common argument from the apple industry, and from scientists
who spend their lives pooh-poohing the threats from farm chemicals
(such as Bruce Ames and Lois Gold[9]), was this: mice were given such
high doses of Alar and UDMH that they were poisoned, so it's not fair
to claim that Alar or UDMH causes cancer at lower doses. In technical
jargon, the mice were given Alar at levels that exceeded their "maximum
tolerated dose" or MTD. Today, in modern cancer tests, typically a
group of animals is given a dose just below the MTD, another group is
given half the MTD and a third group is given zero. The original
studies by Bela Toth in 1973 and 1977 (see REHW #529) gave all the mice
only one dose --23.3 milligrams of UDMH per kilogram of body weight per
day (mg/kg per day). This dose did exceed the MTD and some of the
animals suffered liver damage. However, this dose also produced rare
cancers of the blood vessels in 42 out of 50 mice, providing an
important clue to the characteristics of UDMH.

When EPA finally forced Uniroyal to conduct new studies of UDMH in mice
in the period 1987-1991, mice were given 13 mg/kg per day and 7.3 mg/kg
per day. Even Bruce Ames and Lois Gold had to admit that 7.3 mg/kg per
day did not approach the MTD,[10] yet this amount of UDMH caused cancer
in 31 out of 67 mice (46%) and the 13 mg/kg per day dose caused cancer
in 67% of the exposed mice.[11] Despite whatever shortcomings the Toth
studies may have had, Toth's 1973 and 1977 findings were corroborated
by Uniroyal's studies, using up-to-date protocols. Alar/UDMH DOES cause
cancer and no prudent parent would want his or her infants or children
to eat or drink such a substance. Even if Bruce Ames were correct when
he asserts that the vast majority of cancer-causing chemicals in our
food are naturally-occurring --an assertion that has many problems of
its own --who in their right mind would expose their infant or child to
an ADDITIONAL, unnecessary, human-created danger from Alar/UDMH if they
could avoid it?

In November of 1989, Uniroyal voluntarily took Alar off the market in
the U.S. in response to public anger. The public was no doubt angry at
being lied to repeatedly by government, Uniroyal, grocery stores, and
the apple growers' association. Uniroyal recalled existing supplies of
Alar, then repackaged and re-labeled them B-Nine, for use on flowers.
(Alar and B-Nine are separate Uniroyal products with identical chemical
composition.) A Material Safety Data Sheet (MSDS) for B-Nine issued by
Uniroyal in 1990 said "no evidence of carcinogenicity."[12]

In 1992, based on the Uniroyal studies, EPA reduced its estimate of the
cancer danger from Alar/UDMH by half, to about 23 cancers per one
million people exposed for a lifetime.[13] However, in 1993, the
National Academy of Sciences told EPA that it should be multiplying by
another safety factor of 10 when calculating the hazards of chemicals
to children because children are more sensitive than adults.[14] If we
follow the National Academy of Science's advice, the latest assessment
of the Alar hazard would be 23 x 10 = 230 cancers per million children
exposed. Given the uncertainties surrounding any such assessment, this
is not different from NRDC's 1989 estimate of the hazard, which was 240
cancers per million children exposed. And that is where the science of
Alar stands today.